Robert Ward of Eloxx Pharmaceuticals is on his second tour of duty as chief executive officer of an early-stage biotech. That makes him the perfect “real-life” CEO to react to a recent editorial about a “speculative” CEO who says to her colleagues: “We outsource, therefore we exist.” Ward’s initial thought? “Don’t put Descartes before the horse."
Outsourced GMP-regulated activities have clear requirements, including the use of quality-technical agreements (QTAs). The principles described in this article may be applied to both commercial and precommercial stages of the product life cycle and to any relationship with suppliers that provide outsourced GMP-regulated activities.
Bioburden is mobile, growing, contaminating, and touching everything we do, but it can be controlled if we understand it and follow some basic concepts. This article will focus on the EU grades B, C, D, and CNC in biotech and aseptic facilities.
The first article in this two-part series described five best practices Merck undertook to effectively extend its capacity through strategic outsourcing to external partners. Here are the final five best practices, which focus on building a strong foundation with external partners.
Are you up to the task of bringing a biologic drug to market? Do you have a strategy and plan for moving forward? Here we explore, from a biopharma process development and manufacturing perspective, some of the questions to consider in order to map out a successful pathway and avoid pitfalls along the way.
Through proper implementation of ICH Q12 tools and enablers, the industry could manage CMC changes effectively under a company’s pharmaceutical quality system with less need for extensive regulatory oversight prior to implementation.
In the bioprocessing industry, in order to make full use of upstream advances in an efficient manner, it is essential that downstream processes are intensified.
This article outlines six recent regulatory changes in China intended to protect patient safety as well as reduce regulatory burdens and minimize delays.
This white paper outlines how connectivity and comprehensive automation solution can facilitate technology transfer and scaling from process development to final manufacturing scale.
Through common sense and creative thinking, the industry can discover new ways to achieve success and sustainability in the biosimilar market.
Proper implementation of QbD can potentially provide three main benefits for development.
Tips to prevent bioburden entry and proliferation, and reduce the complexity of the equipment and processes involved.
Generic pharmaceutical manufacturers are facing a business dichotomy: The overall market for generic drugs is growing but at a slower pace as the number of branded drugs entering the market is shrinking, diminishing opportunities to capitalize on expiring patents. Consequently manufacturers face numerous challenges that can significantly impact operational efficiencies and revenue growth.
Shifting and compacting markets, disappearing branded drug queues, economic pressures, and an influx of manufacturers entering the generic market are all contributing to shrinking individual revenue streams, causing many companies to map out new avenues to grow market share. The challenges are formidable, as generic manufacturers seek new products, business models, and more efficient business practices to overcome revenue-threating risks.
Outsourced Pharma provides comprehensive analysis and exclusive content from thought leaders for the advancement of global outsourcing of drug development and manufacturing. We offer readers of our website and participants of our conferences – our Outsourced Pharma community – a deeper exploration and understanding of the relationships between pharmaceutical and biotechnology organizations with their service providers, and an open channel of communication.
About Outsourced Pharma Conferences
Outsourced Pharma Conference & Exhibition is a vibrant forum for thought-leadership and the application of best practices for professionals engaged in outsourcing drug development and manufacturing. These conferences and exhibitions form a community for networking and discussing topics most relevant to sponsor-provider partnerships and supply-chain management, within an open format that promotes panel and attendee interaction.
About OutsourcedPharma.com
OutsourcedPharma.com provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and healthcare markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their bio and pharma sponsors.
Tips to prevent bioburden entry and proliferation, and reduce the complexity of the equipment and processes involved.
Single-use technology is well-established and made its way into commercial licensed facilities, but there is more innovation in this field which will enhance its versatility into new markets and technologies.
Once you have successfully encapsulated an (API), the next task is to characterize that product and understand its release kinetics, such that it can be labeled and prepared for subsequent studies. Following are some lessons learned from characterizing the end product.
For those companies competing to push the boundaries of innovation, a fear of implementing QbD (quality by design) might end up being the biggest threat in the race to the finish.
If you have decided to add capacity in-house, you need to consider which location enables you to meet demand. Having knowledge of the local operating environment and regulatory considerations is vital.
